The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction

NCT ID: NCT06768437

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-12
• Study Completion Date: 2037-08-31

Brief Summary

In this study the investigators are aiming to recruit 130 patients with heart failure with preserved ejection fraction who are obese and non-obese to undergo CT and MRI scans, as well as some other investigations including blood tests, to help investigate if having more fat around the heart leads to worse heart function in this condition. This may lead to the development of new treatments aimed at lowering fat levels around the heart and in the rest of the body, specifically to treat HFpEF.

Detailed Description

Dysregulated adipose tissue, in particular epicardial adipose tissue (EAT; fat around the heart) may be central to the pathogenesis of obesity related HFpEF. Existing studies have been limited by selection bias (only including obese cohorts), limited cardiac structural and functional assessment (primarily using echocardiography) and lack of corroborating biological data to imply causality. Pilot data demonstrate important associations between EAT with concentric LV remodelling in cohorts at high risk of HFpEF.

Further exploration of the role of EAT and other ectopic fat depots in patients with HFpEF with and without obesity, will provide novel insights into mechanisms by which adiposity drives development of HFpEF.

In this single centre, prospective, case-control study the investigators will recruit participants with HFpEF with and without obesity (total N=130) and utilise multimodality imaging to comprehensively characterise the role of excess adiposity and ectopic fat, specifically EAT, to cardiac dysfunction in HFpEF.

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with HFpEF

Obese and non-obese participants with heart failure with preserved ejection fraction

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study.
• Aged ≥18 years old
• Diagnosed with HFpEF and diagnosis confirmed by an experienced cardiologist using the HFA-PEFF diagnostic algorithm
• Echocardiogram performed within 12 months
• Able to understand written English

Exclusion Criteria

• LV ejection fraction <45%
• Severe primary valvular heart disease
• HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease
• Known heritable, idiopathic or drug-induced pulmonary arterial hypertension
• Absolute contraindications to cardiac CT or MRI including estimated glomerular filtration rate (eGFR) ≤30ml/min/1.73m2. Patients with MRI-compatible devices are be excluded.
• Women who are pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Glenfield Hospital, University Hospitals of Leicester

Leicester, Leicestershire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Gaurav S Gulsin, MBChB(Hons)

Role: CONTACT

gg149@le.ac.uk

+44 (0)116 258 3038

Sarah L Ayton, MBBS

Role: CONTACT

sa768@le.ac.uk

Facility Contacts

Sarah L Ayton, MBBS

Role: primary

sa768@leicester.ac.uk

+44 (0)116 258 3038

Other Identifiers

1003

Identifier Type: -

Identifier Source: org_study_id